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Impact of Internal Menstrual Protections on Immunity and Vaginal Microbiota

NCT07199998 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 300

Last updated 2026-04-09

No results posted yet for this study

Summary

The availability, effectiveness, and safety of menstrual protection represent a key public health issue. However, research on women's menstrual and sexual health remains extremely limited. Whether societal or pathological, many hypotheses are emerging regarding the effects of menstrual protection products, yet little attention has been given to the products themselves, their societal role, or their physiological and pathological consequences. Internal menstrual products, such as tampons and menstrual cups, are widely used but are subject to limited regulatory oversight, and few studies have investigated their long-term effects on vaginal health.

This study aims to investigate how different types of menstrual protection influence vaginal microbiota, immune responses, and the recurrence of gynecological conditions such as bacterial vaginosis, mycosis, or dysbiosis. Biological samples (vaginal, cervical, urinary, and blood) will be collected to analyze vaginal microbiota composition and local immunity. Participants will be divided into three groups based on their main type of menstrual protection: menstrual cup users, tampon users, and external pad users. The study will compare these groups to assess potential differences in vaginal health and immune response related to menstrual product use.

Conditions

  • Sexual Transmitted Disease
  • Vaginosis, Bacterial
  • Mycosis
  • Urogenital Disease
  • HPV
  • Dysbiosis
  • Toxic Shock Syndrome
  • Menstrual Cup

Interventions

OTHER

Samples collection (whole blood, urine, vaginal and cervical cells)

During the clinical visit, samples will be collected from participants, including blood, urine, and vaginal and cervical cells. These samples will be used for a range of analyses, including determination of the vaginal microbiota composition and sequencing, cytokine profiling, and assessment of local immunity through flow cytometry using CyTOF technology. Urine samples will be analyzed for pollutants such as phthalates and bisphenol, while blood samples will be used for blood cell counts.

Sponsors & Collaborators

  • Institut Alfred Fournier

    collaborator UNKNOWN

  • Centre National de la Recherche Scientifique, France

    lead OTHER

Principal Investigators

  • Samuel Alizon, Doctor in Biology · Centre National de la Recherche Scientifique, France

Eligibility

Min Age
18 Years
Max Age
49 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-04-07
Primary Completion
2027-03-31
Completion
2027-03-31

Countries

  • France

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07199998 on ClinicalTrials.gov